Subjects With Resectable and Localized Gastric Cancer Clinical Trial
Official title:
Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers(Neo-Chance Study)
This is a phase II, open-label, prospective single-centered study. Subjects who meet the inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2) esophageal cancer and 3) hepatocellular carcinoma. Each cancer cohort group will be treated with two cycles of neoadjuvant immune checkpoint inhibitor of IMC-001 (1 cycle = 2 weeks) followed by curative resection and be followed up consecutively.
This is a phase II, open-label, prospective single-centered study. Subjects who meet the
inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2)
esophageal cancer and 3) hepatocellular carcinoma. Each cancer cohort group will be treated
with two cycles of neoadjuvant immune checkpoint inhibitor of IMC-001 (1 cycle = 2 weeks)
followed by curative resection and be followed up consecutively.
The sample size of the study is determined based on a major pathologic response rate (primary
endpoint) and by using Simon's single stage design from the subjects who receive preoperative
neoadjuvant therapy of IMC-001.
In each cancer cohort group, the null and alternative response rates are assumed as 5% and
20%, respectively. This provides a power of 80% when calculating the difference between major
pathologic response rates of 5% and 20% in two-tailed significance level of 0.153 (Type I
error[two-tailed] of 15.3%). In order to reject the null hypothesis, at least two major
pathological respondents are needed among 14 assessable subjects for each cancer cohort.
After choosing the margin of safety as 10%, each cancer cohort will require 16 subjects and
therefore a total of 48 subjects will be enrolled into the study.
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